AB1457 OPALE: A PROSPECTIVE OBSERVATIONAL STUDY OF THE REAL-WORLD USE OF AN ADALIMUMAB BIOSIMILAR AND EVALUATION OF NUTRITIONAL STATUS ON THE THERAPEUTIC RESPONSE. PATIENTS NUTRITIONAL STATUS AT BASELINE
Authors: M. Soubrier, M. Viguier, L. Peyrin-Biroulet, S. Czernichow
Journal: Annals of the Rheumatic Diseases (2022)

Background Chronic inflammatory diseases treatment has been greatly improved since the introduction of TNF inhibitors and later, of their biosimilars. In addition, epidemiological and interventional studies suggest a pathophysiological or therapeutic role, respectively, of nutrition in Inflammatory Rheumatic Diseases (IRDs). Objectives The objective of the OPALE observational study was to describe in real life the profile of patients treated with an adalimumab biosimilar and to assess the impact of nutrition on disease evolution and response to treatment. Methods The study planned a one-year follow-up of patients with at least three visits: inclusion, six months and one year. In this study, 754 patients treated with Fresenius-Kabi adalimumab were included: 54.4 % of patients with an IRD, 42.8 % with Inflammatory Bowel Disease (IBD) and 2.8 % patients with a psoriasis. Patients’ condition was assessed using a Clinical Global Impression of disease scale (CGI, primary end point of the study). Nutritional status was assessed through clinical data (weight, BMI (Body Mass Index), abdominal circumference) and the available biological analyses results. Screening for sarcopenia was based on a SARC-F score ≥ 4. Nutritional behavior was assessed using a diet questionnaire with a list of 48 foods divided into 6 classes (Fruits &amp; vegetables, meat, fish &amp; eggs, dairy products &amp; fats, starchy foods, sweet foods and drinks). Foods voluntarily withdrawn due to illness and those avoided at acute flare-ups were recommended to be reported. This analysis aims to describe IRD patients’ nutritional status at baseline. Results From 754 included patients, 410 patients presented with an IRD (Psoriatic Arthritis (PsA), n= 80 / Rheumatoid Arthritis (RA), n=102 / SpondyloArthritis (SpA), n=228). Mean patients’ age was 47.7± 14.1 years, 56% are female, mean BMI was 26.0 ± 5.4 kg/m 2 . From this IRD population, 28.5% of patients have a family history of chronic inflammatory disease. Mean disease duration was of 6.4 ± 8.4 years. Concerning the previous IRD treatment, 47.4% of patients had previously been treated by methotrexate among them 58% were still receiving this treatment at inclusion. Among IRD patients recruited in OPALE study, 72.8% received Fresenius Kabi adalimumab as their first biotherapy. Most of patients were assessed on the CGI scale as markedly ill (50.7%) or moderately ill (29.9%) and 110 patients (37.3%) had a score ≥ 4 on the SARC-F questionnaire (mean age 48.9 ± 14.1 years and mean BMI 27.2 ±5.6 kg/m 2 ). Concerning the disease history at baseline, the descriptive analysis of self-administered questionnaire shows that 68.3% of patients may have changed their nutritional behavior because of their illness, by banishing several foods (mean number: 12.7 ± 10.1). These restrictions are increased during flare-ups: 32.7% of patients removed an average of 6.0 ± 5.8 additional foods number. These changes are in part based on the patients’ own beliefs: 17% of them consider that certain foods can improve their illness, 35% of patients think they have identified the foods likely to make it worse (Table 1). Table 1. Patient-reported influence of certain foods on disease PsA RA SpA TOTAL IRD (n=60 ) (n=72 ) (n=177 ) (n=309 ) Patients identifying foods with negative influence 21 22 58 101 37.5% [24.9% - 51.5%] 32.4% [21.5% - 44.8%] 36.0% [28.6% - 44.0%] 35.4% [29.9% - 41.3%] Patients identifying foods with positive influence 9 12 27 48 16.4% [7.8% - 28.8%] 17.6% [9.5% - 28.8%] 17.2% [11.7% - 24.0%] 17.1% [12.9% - 22.1%] Conclusion These preliminary baseline data from OPALE observational study confirm the risk of decreased muscle mass in IRD. Mean BMI of patients screened for sarcopenia is higher than that of non-sarcopenic patients (respectively 27.2 ± 5.6 kg/m 2 and 25.6 ± 4.8 kg/m 2 ; p=0.02). These results plead for a systematic screening for sarcopenia in IRD patients. The risk of sarcopenia could be further aggravated by inappropriate nutritional behaviors aimed at excluding food groups, which would justify dietary education of these IRD patients. Disclosure of Interests Martin SOUBRIER Consultant of: Fresenius Kabi, Manuelle VIGUIER Consultant of: Fresenius Kabi, Laurent Peyrin-Biroulet Consultant of: Fresenius Kabi, Sebastien Czernichow Consultant of: Fresenius Kabi